Gingivaformer

GUDID 07640156473469

Thommen Medical AG

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID07640156473469
NIH Device Record Keyb152a6af-f672-4d71-8a4a-63a49f1521ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameGingivaformer
Version Model Number4.03.550
Company DUNS481614829
Company NameThommen Medical AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107640156473469 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07640156473469]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-07
Device Publish Date2015-09-24

On-Brand Devices [Gingivaformer]

076401564786004.03.558
076401564785944.03.548
076401564785874.03.538
076401564736124.03.520
076401564736054.03.521
076401564735994.03.522
076401564735824.03.523
076401564735754.03.524
076401564735684.03.530
076401564735514.03.531
076401564735444.03.532
076401564735374.03.533
076401564735204.03.534
076401564735134.03.540
076401564735064.03.541
076401564734904.03.542
076401564734834.03.543
076401564734764.03.544
076401564734694.03.550
076401564734524.03.551
076401564734454.03.552
076401564734384.03.553
076401564734214.03.554
076401564734144.03.570
076401564734074.03.571
076401564733914.03.572
076401564733844.03.573
076401564733774.03.574
076401564719154.03.525
076401564719084.03.535

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